Kornimate/medical-research-clean huggingface dataset:
neoadjuvant erlotinib for operable stage ii or iiia nsclc with egfr mutations

Conditions: NSCLC Stage II; NSCLC, Stage IIIA

Summary: this study examines preoperative erlotinib in patients with operable stage ii and iiia non-small-cell lung cancer (nsclc) harboring egfr mutations.

lung cancer remains the most common cause of cancer-related death in the world. non-small-cell lung cancer (nsclc) is the most common type, and it accounts for 85% of cases. unfortunately, the majority of patients with nsclc have metastatic disease at diagnosis. however, even patients with resectable disease have poor survival. the need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable nsclc. in the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced nsclc showed improvements in survival. erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (egfr). the presence of somatic mutations in the kinase domain of egfr strongly correlates with increased responsiveness to egfr tyrosine kinase inhibitors. recently three randomized phase iii trials showed that first-line use of egfr-tkis in patients with egfr mutant nsclc significantly improved response rate and progression-free survival (pfs) compared to platinum-based chemotherapy. these findings prompted this phase ii trial of preoperative erlotinib in patients with operable stage ii and iiia nsclc harboring egfr mutations.

Eligibility criteria:
inclusion criteria: * pathologically confirmed stage ii \& iiia non-small cell lung cancer * egfr exon 19 or 21 mutations * age ≥ 18 years and ecog performance 0\~1 * has measurable lesion by recist 1.1 * no previous chemotherapy or radiation therapy * adequate organ function by following; anc ≥1,500/ul, hemoglobin ≥9.0g/dl, platelet ≥100,000/ul, pao2 ≥ 60 mmhg, serum cr \ 60 ml/min, serum bilirubin \< 1 x unl, ast (sgot) and alt (sgpt) \< 2.5 x unl, alkaline phosphatase \< 5 x unl * written informed consent form exclusion criteria: * previous chemotherapy or radiation therapy * previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ * known allergic history of erlotinib * interstitial lung disease or fibrosis on chest radiogram * active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis) * pregnant or nursing women

Keywords: egfr mutation nsclc
usage of dapagliflozin in the management of type-2 diabetes mellitus: a real world evidence study in indian patients

Conditions: Type 2 Diabetes

Summary: this study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in india. the study targets to enrol 2000 patients with 40 patients per site. the study will be initiated after obtaining written approval of independent ethics committee (iec) /institutional review board (irb) and written informed consent of the patient.

this study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in india. the study targets to enrol 2000 patients with 40 patients per site. the study would enrol t2dm patients who are/were inadequately controlled (hba1c \>7%) with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months prior to study initiation. no study medication will be prescribed or administered as a part of study procedure. patients, who have been treated as per investigators' routine clinical practice and prescribed dapagliflozin 3 months before will be screened for enrolment in study. dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. the study will be initiated after obtaining written approval of independent ethics committee (iec) /institutional review board (irb).

Eligibility criteria:
inclusion criteria: 1. male or female patients with 18 years and above. 2. patients who provide written informed consent. 3. patients with previously diagnosed type-2 diabetes mellitus 4. patients with inadequately controlled diabetes (hba1c \>7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment. 5. patients who are taking dapagliflozin within last 3 months. exclusion criteria: 1. patients with type-1 diabetes mellitus 2. patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study 3. pregnant or lactating women

Keywords: t2d, type 2 diabetes, t2dm
safety and efficacy of the ha-based dermal fillers hyacorp lips and face

Conditions: Dermal Filler

Summary: purpose of this study is the demonstration of safety and efficacy of the dermal fillers hyacorp lips and hyacorp face for restoration of the facial volume and contour.

this is a prospective, multicenter, observational, open label, two-arm, crossover, pmcf clinical trial for demonstration of the safety and efficacy of the ha-based dermal fillers hyacorp lips and hyacorp face for restoration of the facial volume and contour. besides safety aspects, evaluated immediately after the treatment, 4 weeks, 3 and 6 months after the treatment, the performance of the demal fillers are evaluated in the 3 and 6 months follow-up by using gais and wsrs.

Eligibility criteria:
inclusion criteria: * subjects intended for the treatment with hyacorp lips and/or face according to the instructions for use of the product * decision for the treatment with hyacorp lips and/or face was made before the subject was recruited for the clinical trial * subjects signed written informed consent * adult subjects at least 18 years old * all fitzpatrick skin types * area treated with one investigational device - no combination of products in one treatment area exclusion criteria: * tendency to hypertrophic and keloid scarring * intolerance to gram-positive bacteria * prone to active inflammatory or infectious processes * suffering from acute or chronic skin diseases * undergoing anti-coagulant therapy * known allergy to hyaluronic acid * suffering from autoimmune diseases * multiple allergies * pregnancy or lactating women * subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits

Keywords: volume replacement facial filler soft tissue filler hyaluronic acid
study to evaluate the safety and efficacy of paz320 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Treated With Insulin

Summary: this study is to evaluate the effect that paz320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans.

in this study, the investigators seek to evaluate the effect that paz320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans. continuous glucose monitors (cgm) are minimally invasive devices that measure glucose levels in interstitial fluid. a small wire is inserted subcutaneously which transmits the ambient subcutaneous glucose concentration every 5 minutes to a wireless recorder. in usual use, the patient can see these data and graph the previous 1, 3 or 9 hours to identify trends or look back over time (ie over night). in our study, the patient will be blinded to the data so as not to confound results, as it has been noted in another study that patient's blood sugar control was better when they were able to see cgm results and modified their diet. cgm's have been shown to have clinical accuracies of 95.5-98.9% and have been used in clinical trials and found to be safe. having the patient do a finger-stick glucose intermittently during the time they are wearing the cgm improves accuracy.

Eligibility criteria:
inclusion criteria: * male or female subjects, aged 18-75 years; * subjects diagnosed with type 2 diabetes mellitus; * subjects currently on oral agents or insulin; * body mass index 25 to 40 kg/m2; * subjects able to comply with study procedures and sign informed consent * a1c less than or equal to 9% exclusion criteria: * medication (other than diabetes medications or insulin) or dietary supplement known to affect glucose or galactose metabolism * use of acetaminophen-containing products * lactose or galactose intolerance * history of eating disorder * food allergy or severe food intolerance * pregnant or lactating female * subjects with diabetes mellitus treated with very high dose of sulfonylureas (glyburide\>20 mg/day, , glimepiride \>8 mg per day, and glipizide \>20 mg per day) α-glucosidase inhibitors (acarbose ), or meglitinides (repaglinide \>6 mg per day)), ; * subject with gastrointestinal disease that may interfere with absorption of the investigational products at discretion of investigator, including but are not limited to malabsorption syndromes and gastric ulcer; * subject has received any investigational agent within 30 days prior to the first dose of investigational product
the immune response after periodontal treatment

Conditions: Periodontal Diseases

Summary: primary objective: to identify changes in systemic markers of inflammation following periodontal treatment, comparing two standard treatment modalities (hands scaling and ultrasonic scaling) secondary objectives: to investigate bacteraemia, composition and function of oral bacteria, treatment outcomes following periodontal treatment, patient and operator preferences, and treatment time comparing hand scaling and ultrasonic scaling.

effective root surface debridement (rsd) is essential for successful periodontal treatment. myriad studies demonstrate that rsd may be carried out using hand or ulstrasonic instruments with equal efficacy. locally, effective debridement results in reduced inflammation in the gingival tissues, ultimately preserving the dentition. systemically, rsd results in an immediate inflammatory response with elevated c-reactive protein (crp), and cytokines (e.g. interleukin-6 and tumor necrosis factor) detectable in the serum. this systemic inflammation may relate to systemic dissemination of bacteria from the periodontal pockets into the circulation, during instrumentation. bacteria are detectable in serum immediately after instrumentation. the incidence of the bacteraemia varies considerably between different studies, ranging from 13% of patients to 43% to 55%. these studies used different methods of instrumentation; kinane et al used full mouth ultrasonic scale, zhang et al used a mixture of hand and ultrasonic instruments, and heimdahl et al used curettes only. whilst tempting to speculate that ultrasonic instrumentation induces less bacteraemia than hand instrumentation, there is no direct comparison of the effect of ultrasonic instrumentation with hand instrumentation on post treatment systemic inflammation.

Eligibility criteria:
inclusion criteria: * provision of signed, written, informed consent to participate * men or women aged 18 years to 70 years inclusive * periodontal disease requiring treatment at glasgow dental hospital exclusion criteria: * known or suspected high risk for tuberculosis, hepatitis b or hiv infections * require interpreter/non english language written material to understand and provide, or any other reason for being unable to provide written, informed consent * history of bleeding diathesis * females using contraceptive methods. * pregnant or lactacting females. * reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases. * any pharmacological treatment within 3 months before the beginning of periodontal treatment. * specialist periodontal treatment in the previous 6 months. * patients who will not tolerate ultrasonic instrumentation even with local anaesthesia.

Keywords: root surface debridement hand instrumentation ultrasonic instrumentation systemic immune crp
proof-of-concept study assessing vns paired with tones for tinnitus

Conditions: Severe Tinnitus

Summary: this is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (vns) paired with tones for the treatment of severe tinnitus. the study is expected to give preliminary efficacy and safety information.


Eligibility criteria:
key inclusion criteria: * 18 to 65 years of age * diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus. * diagnosis of tinnitus for at least one year * tinnitus severity of 18 or greater on trq cross checked with tq severity of grade 3 or worse key exclusion criteria: * acute or intermittent tinnitus * severe hearing loss * history of significant ear disease such as meniere's disease, ear tumors, or evidence of active middle ear disease. * any other implanted device
effects of pulmonary rehabilitation on clinical outcomes in children with asthma

Conditions: Asthma in Children; Physical Inactivity

Summary: although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. however, the effects of pulmonary rehabilitation in this population, especially in improving the level of physical activity in daily living (padl) and activities of daily living (adls) have not yet been investigated in depth. therefore, the objective of this study is to verify the effects of pulmonary rehabilitation on padl, adl, and other clinical outcomes of children with asthma. for this, a randomized clinical trial will be carried out that will have 2 groups: the control group (cg), which will receive only educational sessions, and the intervention group (ig) which will participate in a pulmonary rehabilitation program with supervised aerobic training performed three times a week with sessions of 60 minutes each. the total duration of interventions in both groups will be 12 weeks. the primary outcomes of this study are padl (assessed using a physical activity monitor - actigraph) and adl; however, the following will also be evaluated: lung function, functional capacity, asthma control, and quality of life. we hypothesized that the performance of regular physical activity and supervised physical exercise by individuals with asthma could positively impact health outcomes with better control of asthma symptoms, better performance in adl and padl, and better quality of life.


Eligibility criteria:
inclusion criteria: * age between 6 and 12 years old; * clinical diagnosis of asthma, established according to the criteria of the global initiative for asthma (gina); * absence of other lung diseases or signs and symptoms of other lung diseases; * absence of cognitive changes; * absence of signs and symptoms of gastroesophageal reflux disease and dysphagia; * clinical stability according to the criteria of the global initiative for asthma (gina); exclusion criteria: * desire of the patient and/or the patient's family to discontinue participation in the study for any reason; * present some new limitations that may interfere with functionality; * comorbidities that prevent or contraindicate the performance of the proposed interventions.
serpin d1 and its role in lung cancer invasion and metastasis

Conditions: Non-Small Cell Lung Cancer

Summary: to evaluate the correlation between serpin d1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

lung cancer is the leading cause of cancer death in taiwan and world wild. although there were progresses in the diagnosis and treatment of lung cancer, the incidence and mortality rate of lung cancer increased in recent years. in many cases, lung cancer is not diagnosed and treated until cancer cells have already invaded surrounding tissues and metastasized throughout the body. only 15% of lung cancer patients were operable at presentation and about half of them had long term survival. the remaining almost died of metastatic disease. detecting lung cancers when they are at their earliest stages, and identify cancers with metastatic potential will have a higher probability of truly curing the disease. molecules that are expressed uniquely or at high level by tumor cells in comparison to normal tissues and that may be secreted into accessible fluids such as blood, urine, or sputum may be useful as lung cancer biomarkers. by using tools in sage genie of cancer genome anatomy project (cgap), we identified a secreted protein, serpin d1, as an overexpressed gene in non-small cell lung cancer as compared with normal lung and any other normal tissue. in an established panel of human lung adenocarcinoma cell lines with different invasive activities (cl1-0 cells and its sublines cl1-1, and cl1-5, in ascending order of activity), we detected that the expression of serpin d1 was higher in cl1-5 than in cl1-0 and cl1-1. according to our preliminary results, we hypothesize that serpin d1 may play a role in lung cancer invasion and metastasis and may serve as a serum biomarker for prognosis stratification. for this study, we are going to evaluate the potential correlation between serpin d1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer patient, pathological proved exclusion criteria: -
a fatty flap taken from the double chin for chin enhancement: a new surgical technique

Conditions: Adiposity; Micrognathism

Summary: the double chin is a troublesome component of the lower third of the face. it gives an embarrassing and unpleasant facial appearance to both men and women leading them to ask for liposuction. moreover, a "receding chin" causes blunting of the cervico-mental angle, a fleshy appearing neck, a disproportion in the profile line of the face with a prominent looking nose, and an irregular mandibular border. this study is about an innovative surgical procedure: instead of doing liposuction of the double chin, the investigators used the fat of this area as a flap to improve a "receding chin". hence both the double chin and the receding chin are treated.

the surgical technique was performed on 10 participants. written informed consent was obtained from all the participants. description of the surgical technique: the investigators began by delineating the undesirable subplatysmal fat located in the submental region, just below the subcutaneous fat. the skin redundancy assessed by the pinch test was excised. under general anesthesia, an incision was made behind the submental crease followed by the excision of the skin excess. the subplatysmal fatty compartment was individualized through a subcutaneous dissection. then, the lower part of the subplatysmal fat was cut to start its separation from the platysma muscle, thus obtaining a real vascularized fatty flap. this flap could be folded on itself, then easily turned over to be fixed on the thin layer of the pre-muscular fat overlying the chin. hemostasis was performed correctly avoiding the establishment of drainage. chin projection and submental rejuvenation were obtained. the advancement of the chin ranged from 3,5 to 12 millimeters. the stability of the translated fat was observed after surgery for more than two years.

Eligibility criteria:
inclusion criteria: * the presence of a "double chin" with slightly redundant skin and a "receding chin" causing a fleshy appearing neck, and a disproportion in the face profile exclusion criteria: * any history of a precedent surgery on the neck, the presence of a traumatic or a burn scar on the cervical region.

Keywords: retrognathia mandibular advancement adipose tissue cervicoplasty
natural matrix protein™ (nmp™) in interbody lumbar fusion

Conditions: Degenerative Disc Disease

Summary: the objective of this study is to evaluate the performance of induce biologics nmp™ when used to promote interbody fusion for degenerative disease of the lumbar spine.

the study involves a retrospective review of patients' medical records and prospective collection of ct scans, x-rays, and patient centered outcome questionnaires. the study population will include up to 135 patients of the spine institute of louisiana (sil) who have been treated with induce biologics nmp™ during a lumbar interbody fusion. all subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. there will be a single prospective visit in this study. this visit will be scheduled at the 12-month (± 2 mo) post-surgery time point.

Eligibility criteria:
inclusion criteria: 1. have clinical or radiological evidence of degenerative disc disease of the lumbar spine. 2. have been treated with induce biologics nmp™ during a lumbar spinal fusion procedure. 3. be at least 18 years of age. 4. have current contact information. 5. be willing and able to provide written informed consent for the prospective part of study participation. 6. be willing and able to undergo a ct-scan and x-rays. 7. be willing and able to complete patient centered outcome questionnaires. exclusion criteria: 1. currently imprisoned. 2. currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin. 3. x-rays or ct-scan are contraindicated. 4. any previous lumbar fusion or arthroplasty surgery at the index level(s)

Keywords: lumbar spine fusion
sorafenib in bac or never-smokers with lung adenocarcinoma

Conditions: Lung Cancer

Summary: open label study of sorafenib

open label study using oral sorafenib 800 mg daily in any stage iii-iv bac lung cancer and stage iii-iv adenocarcinoma of the lung in nonsmokers (less than \< 100 cigarettes lifetime).

Eligibility criteria:
inclusion criteria: * age \> 18 * life expectancy \> 12 weeks * biopsy-proven bac or adenocarcinoma * willing to provide smoking status * selected iiib or stage iv cancer that is incompletely resected or unresectable exclusion criteria: * o2 saturation \< 88% on room air * pregnant or nursing women * surgery or radiation therapy within 4 weeks of starting study * major heart condition within 6 months of starting therapy * certain concomitant medications prohibited

Keywords: bac lung cancer adenocarcinoma of the lung